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Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode.

Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.

Twenty seven (27) patients aged 68 years or above, currently suffering from a major depressive episode, who did not respond to treatment with at least one antidepressant medications in the recommended dosage and duration, or could not tolerate at least two antidepressants.

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Ages Eligible for Study:

68 Years and older (Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosed by a senior psychiatrist as suffering from major depression episode according to DSM-IV (either as a part of a unipolar or a bipolar disorder).

Rating on HDRS ≥ 20.

Age: 68 years and above

Treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and ATHF (antidepressant treatment history form) instruction guidelines.

Gave informed consent for participation in the study.

Negative answers on safety screening questionnaire for TMS.

If referred by a treating psychiatrist, he or she approves of the subject's participation in the study.

Exclusion Criteria:

Axis 2 diagnosis, which is considered prominent to the current depressive episode.

Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.

Attempted suicide in the past year.

Cognitive impermanent - if MMSE < 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion

History of seizure.

History of epilepsy or seizure in first degree relatives.

Any CNS disorder that may increase risk of seizure significantly

History of a significant head injury.

History of any metal in the head (outside the mouth).

Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.

History of frequent or severe headaches.

Use of hearing aids for hearing loss.

Known history of cochlear implants.

History of drug abuse or alcoholism.

Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.

Inadequate communication with the patient.

Under custodial care.

Participation in current clinical study or clinical study within 30 days prior to this study.

Patients suffering from bipolar disorder, not currently treated by mood stabilizers

Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521052